| Primary Device ID | 00860012211913 |
| NIH Device Record Key | 2b5eebd5-2059-48e0-9352-aadf89f5d1e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOLOPASS 2.0 Ultrasound Cable Assembly |
| Version Model Number | 1 |
| Catalog Number | CAB25-0000 |
| Company DUNS | 052770186 |
| Company Name | inTRAvent Medical Partners, L.P. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 999-999-9999 |
| quality@intraventmedical.com | |
| Phone | 999-999-9999 |
| quality@intraventmedical.com | |
| Phone | 999-999-9999 |
| quality@intraventmedical.com | |
| Phone | 999-999-9999 |
| quality@intraventmedical.com | |
| Phone | 999-999-9999 |
| quality@intraventmedical.com | |
| Phone | 999-999-9999 |
| quality@intraventmedical.com | |
| Phone | 999-999-9999 |
| quality@intraventmedical.com | |
| Phone | 999-999-9999 |
| quality@intraventmedical.com | |
| Phone | 999-999-9999 |
| quality@intraventmedical.com | |
| Phone | 999-999-9999 |
| quality@intraventmedical.com | |
| Phone | 999-999-9999 |
| quality@intraventmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860012211913 [Primary] |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860012211913]
Hydrogen Peroxide
[00860012211913]
Hydrogen Peroxide
[00860012211913]
Hydrogen Peroxide
[00860012211913]
Hydrogen Peroxide
[00860012211913]
Hydrogen Peroxide
[00860012211913]
Hydrogen Peroxide
[00860012211913]
Hydrogen Peroxide
[00860012211913]
Hydrogen Peroxide
[00860012211913]
Hydrogen Peroxide
[00860012211913]
Hydrogen Peroxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-19 |
| Device Publish Date | 2025-12-11 |
| 00860012211906 - SOLOPASS 2.0 Patient Interface Device | 2025-12-19 A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Cat |
| 00860012211913 - SOLOPASS 2.0 Ultrasound Cable Assembly | 2025-12-19Ultrasound Cable Assembly includes the probe tip, handle assembly and a connector. |
| 00860012211913 - SOLOPASS 2.0 Ultrasound Cable Assembly | 2025-12-19 Ultrasound Cable Assembly includes the probe tip, handle assembly and a connector. |
| 00860012211920 - SOLOPASS 2.0 Workstation | 2025-12-19 Workstation/ Display with software that uses 2D intra-op ultrasound data to provide simultaneous location data for 3D anatomy. |